FDA recall D-0448-2023

Ecometics, Inc. · Class II · drug

Product

Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756

Reason for recall

CGMP DEVIATIONS

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2023-02-24
Report date
2023-03-15
Termination date
2023-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norwalk, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0448-2023